This observer-blind, randomized, active controlled trial will be conducted among 2-29 year olds in two sites (Mali and The Gambia). The objectives of the study are to assess and compare the immunogenicity and safety of NmCV-5 with that of Menactra.
A total of 1800 eligible participants (who or their parents/guardians have given written informed consent) will be randomised 2:1 (NmCV-5: Menactra) in each of the three age strata 18-29 years, 11-17 years & 2-10 years (400 NmCV-5 recipients & 200 Menactra recipients in each age strata).
Each subject will receive a single dose of study vaccine and will be followed up for 6 months post vaccination during which solicited reactions (for seven days), unsolicited AEs (28 days) and SAEs (until the end of study i.e. 168 days after vaccination) will be collected. A blood sample will be collected at baseline (pre-vaccination) and at day 28 post-vaccination for immunogenicity assessment by a Serum Bactericidal Activity assay using rabbit complement (rSBA).
Condition or disease | Intervention/treatment | Phase |
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Meningococcal Meningitis | Biological: NmCV-5 Biological: Menactra | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1800 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Observer blind |
Primary Purpose: | Prevention |
Official Title: | Phase 3, Observer-blind, Randomized, Active Controlled Trial to Assess the Safety of an Investigational Meningococcal Serogroups ACYWX Conjugate Vaccine (NmCV-5) and Compare Its Immunogenicity to a Licensed Meningococcal Serogroups ACYW Conjugate Vaccine (Menactra®), in Healthy Subjects 2 to 29 Years of Age |
Actual Study Start Date : | August 20, 2019 |
Actual Primary Completion Date : | February 23, 2020 |
Estimated Study Completion Date : | March 30, 2021 |
Arm | Intervention/treatment |
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Experimental: NmCV-5
Subjects in this arm will receive polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X. A single dose of 0.5 mL will be administered intramuscularly. |
Biological: NmCV-5
Polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to C reactive material (CRM) protein. The diluent is Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
Other Name: MenACYWX
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Active Comparator: Menactra
Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra. A single dose of 0.5 mL will be administered intramuscularly. |
Biological: Menactra
Menactra is available as ready to use solution containing polysaccharide antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine
Other Name: MenACYW-D
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Ages Eligible for Study: | 2 Years to 29 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Gambia | |
Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine | |
Fajara, Gambia | |
Mali | |
Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251 | |
Bamako, Mali, BP251 |
Tracking Information | |||||
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First Submitted Date ICMJE | May 23, 2019 | ||||
First Posted Date ICMJE | May 28, 2019 | ||||
Last Update Posted Date | May 21, 2020 | ||||
Actual Study Start Date ICMJE | August 20, 2019 | ||||
Actual Primary Completion Date | February 23, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5) | ||||
Official Title ICMJE | Phase 3, Observer-blind, Randomized, Active Controlled Trial to Assess the Safety of an Investigational Meningococcal Serogroups ACYWX Conjugate Vaccine (NmCV-5) and Compare Its Immunogenicity to a Licensed Meningococcal Serogroups ACYW Conjugate Vaccine (Menactra®), in Healthy Subjects 2 to 29 Years of Age | ||||
Brief Summary |
This observer-blind, randomized, active controlled trial will be conducted among 2-29 year olds in two sites (Mali and The Gambia). The objectives of the study are to assess and compare the immunogenicity and safety of NmCV-5 with that of Menactra. A total of 1800 eligible participants (who or their parents/guardians have given written informed consent) will be randomised 2:1 (NmCV-5: Menactra) in each of the three age strata 18-29 years, 11-17 years & 2-10 years (400 NmCV-5 recipients & 200 Menactra recipients in each age strata). Each subject will receive a single dose of study vaccine and will be followed up for 6 months post vaccination during which solicited reactions (for seven days), unsolicited AEs (28 days) and SAEs (until the end of study i.e. 168 days after vaccination) will be collected. A blood sample will be collected at baseline (pre-vaccination) and at day 28 post-vaccination for immunogenicity assessment by a Serum Bactericidal Activity assay using rabbit complement (rSBA). |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: Observer blind Primary Purpose: Prevention
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Condition ICMJE | Meningococcal Meningitis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Chen WH, Neuzil KM, Boyce CR, Pasetti MF, Reymann MK, Martellet L, Hosken N, LaForce FM, Dhere RM, Pisal SS, Chaudhari A, Kulkarni PS, Borrow R, Findlow H, Brown V, McDonough ML, Dally L, Alderson MR. Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine containing serogroups A, C, Y, W, and X in healthy adults: a phase 1, single-centre, double-blind, randomised, controlled study. Lancet Infect Dis. 2018 Oct;18(10):1088-1096. doi: 10.1016/S1473-3099(18)30400-6. Epub 2018 Aug 14. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
1800 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 30, 2021 | ||||
Actual Primary Completion Date | February 23, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 2 Years to 29 Years (Child, Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Gambia, Mali | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03964012 | ||||
Other Study ID Numbers ICMJE | ACYWX-03 CVIA 071 ( Other Identifier: PATH ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Serum Institute of India Pvt. Ltd. | ||||
Study Sponsor ICMJE | Serum Institute of India Pvt. Ltd. | ||||
Collaborators ICMJE | PATH | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Serum Institute of India Pvt. Ltd. | ||||
Verification Date | May 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |